Trial of Glutamine and Antioxidant Supplementation in Critically Ill Patients
NCT ID: NCT00133978
Last Updated: 2021-01-07
Study Results
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View full resultsBasic Information
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COMPLETED
NA
1223 participants
INTERVENTIONAL
2005-04-30
2012-05-31
Brief Summary
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Detailed Description
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Critically ill patients experience a degree of hyperinflammation, cellular immune dysfunction, and oxidative stress. Supplementation with key nutrients, like glutamine and antioxidants, is most likely to have a favourable effect on these physiological parameters leading to an improvement in clinical outcomes. The results of two separate meta-analyses suggested that glutamine and antioxidants may be associated with improved survival. We have recently completed a dosing study to determine the maximal tolerable dose (MTD) of glutamine dipeptides and antioxidants in critically ill patients with evidence of hypoperfusion. The purpose of this protocol is to evaluate the effect of high dose glutamine and antioxidant supplementation on mortality in a large scale randomized trial.
Study Intervention:
Patients will be randomized to receive glutamine supplementation or antioxidant supplementation (or respective placebo).
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
QUADRUPLE
Study Groups
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Glutamine
Glutamine supplementation
Glutamine
0.35 gm/kg/day parenterally and 30 gms/day enterally
Antioxidants
Antioxidant supplementation
Antioxidants
500 micrograms of selenium/day parenterally and selenium 300 microgram, zinc 20 mg, beta carotene 10 mg, vitamine E 500 mg and vitamin C 1500 mg per day enterally
Glutamine + Antioxidants
Glutamine and antioxidant supplementation
Glutamine + Antioxidants
0.35 g/kg/day glutamine parenterally and 30 g/day of glutamine enterally. 500 mcg selenium parenterally plus the following administered enterally: selenium 300 mcg, zing 20 mg, beta-carotene 10 mg, vitamin E 500 mg and vitamin C 1500mg
Placebo
Non-isonitrogenic, iso-caloric placebo solution
Placebo
Normal saline intravenously and EN placebo formula (from Fresenius Kabi, Germany)
Interventions
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Glutamine
0.35 gm/kg/day parenterally and 30 gms/day enterally
Antioxidants
500 micrograms of selenium/day parenterally and selenium 300 microgram, zinc 20 mg, beta carotene 10 mg, vitamine E 500 mg and vitamin C 1500 mg per day enterally
Glutamine + Antioxidants
0.35 g/kg/day glutamine parenterally and 30 g/day of glutamine enterally. 500 mcg selenium parenterally plus the following administered enterally: selenium 300 mcg, zing 20 mg, beta-carotene 10 mg, vitamin E 500 mg and vitamin C 1500mg
Placebo
Normal saline intravenously and EN placebo formula (from Fresenius Kabi, Germany)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 2 or more organ failures related to acute illness
Exclusion Criteria
* Patients who are moribund
* Lack of commitment to aggressive care
* Absolute contraindication to enteral nutrients
* Severe acquired brain injury
* Routine elective cardiac surgery
* Primary admission of burns \> 30% body surface area
* Weight \< 50 kgms or \> 200 kgms
* Pregnant or lactating patients
* Previous randomization in this study
* Enrollment in a related ICU interventional study
* Child's class C liver disease
* Metastatic cancer with life expectancy \< 6 months
* Seizure disorder requiring anticonvulsant medication
18 Years
ALL
No
Sponsors
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Fresenius Kabi
INDUSTRY
Daren K. Heyland
OTHER
Responsible Party
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Daren K. Heyland
Director
Principal Investigators
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Daren Heyland, MD
Role: STUDY_CHAIR
Clinical Evaluation Research Unit, Kingston General Hospital
Locations
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Univ. of Colorado at Denver and Health Sciences Center
Aurora, Colorado, United States
University of Louisville
Louisville, Kentucky, United States
Miami Valley Hospital
Dayton, Ohio, United States
University of Texas
Houston, Texas, United States
Fletcher Allan Centre
Burlington, Vermont, United States
UZ Brussels
Brussels, , Belgium
University Hospital
Liège, , Belgium
Royal Alexandra Hospital
Edmonton, Alberta, Canada
Grey Nun's Hospital, Edmonton
Edmonton, Alberta, Canada
Vancouver Hospital
Vancouver, British Columbia, Canada
St Paul's Hospital
Vancouver, British Columbia, Canada
Royal Jubilee Hospital
Victoria, British Columbia, Canada
Victoria General Hospital
Victoria, British Columbia, Canada
St. Boniface General Hospital
Winnipeg, Manitoba, Canada
Health Science Centre
Winnipeg, Manitoba, Canada
Capital Health Queen Elizabeth II HSC
Halifax, Nova Scotia, Canada
St Joseph's Healthcare
Hamilton, Ontario, Canada
Kingston General Hospital
Kingston, Ontario, Canada
London HSC Victoria Campus, ON
London, Ontario, Canada
Ottawa Hospital
Ottawa, Ontario, Canada
Ottawa Hospital Civic Hospital
Ottawa, Ontario, Canada
Sunnybrook & Women's College, Toronto
Toronto, Ontario, Canada
Mt Sinai Hospital
Toronto, Ontario, Canada
Hopital Maisonneuve-Rosemount
Montreal, Quebec, Canada
Royal Victoria Hospital
Montreal, Quebec, Canada
Montreal General
Montreal, Quebec, Canada
Hopital de Sacre-Coeur
Montreal, Quebec, Canada
Enfant-Jesus
Québec, , Canada
Universitatsklinikum der Ernst-Moritz-Arndt-Universitat
Greifswald, , Germany
Asklepios Kliniken Hamburg Altona
Hamburg, , Germany
University Medical Center Schleswig-Holstein
Kiel, , Germany
Universitatsklinikum Schleswig-Holstein Campus Luebeck
Lübeck, , Germany
CHUV
Lausanne, , Switzerland
University of Zurich
Zurich, , Switzerland
Countries
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References
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Heyland DK, Dhaliwal R, Drover JW, Gramlich L, Dodek P; Canadian Critical Care Clinical Practice Guidelines Committee. Canadian clinical practice guidelines for nutrition support in mechanically ventilated, critically ill adult patients. JPEN J Parenter Enteral Nutr. 2003 Sep-Oct;27(5):355-73. doi: 10.1177/0148607103027005355.
Heyland DK, Dhaliwal R, Suchner U, Berger MM. Antioxidant nutrients: a systematic review of trace elements and vitamins in the critically ill patient. Intensive Care Med. 2005 Mar;31(3):327-37. doi: 10.1007/s00134-004-2522-z. Epub 2004 Dec 17.
Novak F, Heyland DK, Avenell A, Drover JW, Su X. Glutamine supplementation in serious illness: a systematic review of the evidence. Crit Care Med. 2002 Sep;30(9):2022-9. doi: 10.1097/00003246-200209000-00011.
Heyland D, Muscedere J, Wischmeyer PE, Cook D, Jones G, Albert M, Elke G, Berger MM, Day AG; Canadian Critical Care Trials Group. A randomized trial of glutamine and antioxidants in critically ill patients. N Engl J Med. 2013 Apr 18;368(16):1489-97. doi: 10.1056/NEJMoa1212722.
Heyland DK, Elke G, Cook D, Berger MM, Wischmeyer PE, Albert M, Muscedere J, Jones G, Day AG; Canadian Critical Care Trials Group. Glutamine and antioxidants in the critically ill patient: a post hoc analysis of a large-scale randomized trial. JPEN J Parenter Enteral Nutr. 2015 May;39(4):401-9. doi: 10.1177/0148607114529994. Epub 2014 May 5.
Related Links
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Click here for more information about this study: A Randomized Trial of Glutamine and Antioxidant Supplementation in Critically Ill Patients
Other Identifiers
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EudraCT-No: 2007-001831-73
Identifier Type: -
Identifier Source: secondary_id
REDOXS
Identifier Type: -
Identifier Source: org_study_id
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